Pax-I3D Smart Imaging System Overview; Standards And Regulations - VATECH PaX-i3D Smart Manual Del Usuario

1 PaX-i3D Smart Imaging System Overview

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PaX-i3D Smart(PHT-30LFO) User Manual
The PaX-i3D Smart is an advanced digital dental diagnostic system that
incorporates Panoramic (PANO), Cephalometric (CEPH), and 3D CT imaging
capabilities into a single system.
The PaX-i3D Smart system is intended for use to take a panoramic,
cephalometric and CT image of the oral and craniofacial anatomy to provide
diagnostic information for adult and pediatric patients.
The PaX-i3D Smart may only be used by dentists, X-Ray technicians and other
professionals who are licensed to perform X-Rays by the law of the region in
which it is being used.

Standards and Regulations

The PaX-i3D Smart is designed and manufactured to meet the following standards:
IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18, 2008
The CE symbol grants this equipment compliance with the European Direc-
tive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class
IIb device.
UL symbol grants this equipment compliance with the UL 60601-1 / CAN/
CSA C22.2 No.601.1
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment: IPX0
Protection against electric shock: Class 1 equipment, Type B Applied Parts
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